Identity
- Trade Name
- MICROAIRE EUDAMEDMICROAIRE® FDA UDI
- Generic Name
- Disposable surgical irrigation/aspiration system FDA UDI
- Device Name
- Disposable Pulse Lavage EUDAMEDDisposable Pulse Lavage Hip Kit FDA UDI
- Model / Reference
- 201-04-00 EUDAMEDFDA UDI
- Description
- Disposable Pulse Lavage Hip Kit FDA UDI
Identifiers
- Catalog Number
- 201-04-00 FDA UDI
- Primary DI / UDI-DI
- 16972130470149 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16972130470149 EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Disposable surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microaire by Apex (Suzhou) Medical Products Company — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16972130470149 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Apex (Suzhou) Medical Products Company
- EUDAMED SRN
- CN-MF-000031975
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 5b27a3e2-9337-44c1-9a9f-6db42dfe803e 61 fields · synced Oct 5, 2026
- FDA UDI 5d171fc4-f26a-4312-864e-4b957fca4289 34 fields · synced May 30, 2026